Process for Requesting Cell Lines

Investigators should read all of the following information prior to submitting a request for cell lines. Click the button below to begin the submission process.

CELL LINES SUB-STUDIES OVERVIEW

While the initial goal of PPMI was to collect standardized longitudinal samples with corresponding clinical data for use by qualified researchers to advance biomarker validation studies, PPMI has since expanded to generate fibroblasts and induced pluripotent stem cell (iPSC) lines from PPMI subjects. Fibroblasts and iPSCs derived from skin biopsies from 20 Parkinson?s disease (PD) subjects and 5 healthy control (HC) subjects are available from an initial pilot study performed with the New York Stem Cell Foundation (NYSCF).

In 2016, PPMI began generating iPSCs from blood as part of the Golub Capital iPSC PPMI Sub-study. an expanded sub-study with Cellular Dynamics International (CDI). The goal of the Golub Capital iPSC PPMI Sub-study is to generate iPSCs from subjects across all PPMI study arms, including affected and unaffected genetic mutation carriers, at a subset of US sites.

The PPMI Biospecimen Review Committee (BRC)
The BRC has been established to review applications seeking access to PPMI biospecimens and cell lines. Following evaluation of an application, the BRC will approve or decline access to PPMI cell lines. The BRC will meet every other month to review all applications received in time for the meeting. All applications submitted to the PPMI BRC will be treated confidentially. Click here to read our Conflict of Interest statement.

USE OF CELL LINES

The use of cell lines falls outside of the realm of the standard PPMI Intellectual Property (IP) policy. Any user of cell lines may generate and claim proprietary IP rights on research tools developed from use of cell lines (?Inventor?). IP on compounds developed and/or tested with any research tool created through or from PPMI cell lines in conformity with PPMI IP policies may remain with the Inventor.

PROCEDURE TO APPLY FOR ACCESS TO CELL LINES

Please read the following section carefully to understand the process to apply for use of cell lines (fibroblasts and iPSCs) collected as part of the PPMI study.

The application should be a brief two-page summary that describes the studies proposed and the rationale for these analyses, including the significance of both the study question and the specific project. Applications should also outline the number of samples from unique subjects and type of cell line requested.

All applications must be submitted online using the PPMI Cell Lines Request system. Before uploading this document, investigators are required to agree to the PPMI Cell Lines Use Agreement and must provide basic biographical information. Click this link to access the PPMI Cell Lines Request system: www.PPMI-info.org/cell-lines.

The PPMI study encourages interested investigators, whether associated with PPMI or not, to apply for use of PPMI cell lines. Because cell lines are a more renewable resource as compared to the biospecimen collected in PPMI, the evaluation criteria cell lines requests are quite different. While all of the other resources available from PPMI are reserved for the validation of progression markers with positive data from other human cohorts, PPMI cell lines may be requested for biomarker discovery work. In addition, investigators interested in conducting research in other neurodegenerative disease areas are also welcome to apply for access to cell lines. Please note that priority may be given to applications requesting cell lines for PD research.

1. Study Rationale: Applications for PPMI cell lines should briefly describe the studies proposed and the rationale for these analyses, including the significance of both the study question and the specific project.

2. Biosamples Requested: In the application for PPMI cell lines, please outline the number of samples from unique subjects and type of cell line requested, including descriptions of characteristics (e.g. PD, control, genotype, any specific clinical parameters) and specific biosample parameters (e.g. method of collection, QC) if relevant. Applications should include a clear justification for the number and amount of samples requested. If results from the proposed study will be combined with those obtained from other samples, the application should include an explanation of how the requested samples will fit in with the overall study design.

3. Project Details: Applications for cell lines must define the proposed study hypothesis and describe the study design, including methods that will be used to test it. Applications must describe the specific procedures by which the samples will be tested and analyzed, including relevant data or citations demonstrating experience with these techniques. The application should contain details on the power of the proposed study and anticipated size of a detectable effect.

4. Submission of Data: PPMI requires that investigators submit a report of completed analyses to the Biospecimen Review Committee (BRC). The BRC reserves the right to deposit these analyses in the PPMI study database for use by the research committee. Applications should describe what data and results will be returned to the BRC, and specify timelines for project completion and submission.

5. Future Objectives: Explain how a successful outcome of the proposed plan would lead to better understanding of PD and/or would address critical questions essential to development of PD therapies or biomarkers.

A proposal to request cell lines will receive one of the following decisions from the BRC:

1. Approval of application: After a positive review by the BRC, applicants will be informed of their selection and be contacted to provide additional information to facilitate the logistics of accessing the cell lines.

2. Approval of the application contingent upon requested changes: Due to the single-stage nature of the request process for PPMI cell lines, the BRC does not have the ability to ask investigators to revise proposals based on its recommendations. To ensure that no opportunities for PPMI cell lines to be used for potentially interesting and valuable studies are missed, the BRC may approve a proposal contingent upon the accommodation of specific changes to the study suggested by the BRC. In a situation like this, the investigator will be given the opportunity to accept the proposed changes or to decline and forego PPMI cell line access.

3. Disapproval of the application: Application was not deemed to be of significant merit and/or the proposed assays were not of sufficient quality to justify use of the PPMI cell lines.

Approved projects will obtain the cell lines from the PPMI Biorepository Core. Before any cell lines or data will be released to the investigator(s) the following administrative items must be completed:

o Acknowledgment and acceptance of PPMI Cell Lines Use Agreement by the investigator(s)
o Receipt of regulatory approval (i.e. IRB) by the relevant institution(s) to handle/work with the cell lines
o Signed Material Transfer Agreement between PPMI Biorepository Core and the investigator?s institution

To ensure that experiments occur on a timely basis, investigators will be required to complete the administrative necessities outlined above within three months of receipt of BRC approval. Failure to complete these items in a timely manner will result in forfeit of the approval to use PPMI samples.

All cell lines will be shipped from the PPMI Biorepository Core to the receiving investigator with the de-identified PPMI subject ID. Investigators using PPMI cell lines are required to submit a report of completed analyses to the BRC. The BRC reserves the right to deposit these analyses in the PPMI study database for use by the research committee.

Confidentiality

MJFF and the BRC treats all Letters of Intent (LOI), Full Proposals, research projects and associated research information (collectively, the ?Confidential Information?) in confidence using no less than reasonable care in protecting such Confidential Information from disclosure to third parties who do not participate in the grant review process and MJFF assessments. All Confidential Information will be used by the BRC, MJFF and its grant reviewers (?Reviewers?) only internally for the purposes of reviews and assessments, and will be shared only in accordance with its sharing policy stated herein. Notwithstanding Reviewers? obligations regarding such Confidential Information, such obligations cover any information retained in their unaided memories and may not be used without the permission of the disclosing party. Notwithstanding the foregoing, the obligations governing the disclosure and use of Confidential Information do not apply with respect to Confidential Information that it can be demonstrated:

(a) was generally known to the public prior to the effective date when the LOI was submitted; or (b) becomes generally known to the public through no unlawful or unauthorized act of omission by any recipient of Confidential Information, or in violation of this review process; or (c) was independently developed by any recipient prior to the effective date of this review process; or (d) was disclosed to a recipient by a third party who has the right to make such disclosure.

If any recipient of Confidential Information is requested to produce any of the Confidential Information pursuant to a legal or governmental proceeding, such recipient shall give the applicant or other owner of such Confidential Information (the ?Discloser?) as much prior notice of such requirement as is reasonably practicable under the circumstances and shall use its reasonable efforts to assist the Discloser of such Confidential Information in objecting to such request. If a recipient is compelled to disclose any of the Confidential Information pursuant to such legal or governmental proceeding, such recipient shall use its reasonable efforts to assist Discloser in obtaining confidential treatment for such Confidential Information, will disclose only that portion of the Confidential Information which is responsive to the order, and will provide the Discloser with any copies of Confidential Information so disclosed; provided that such Confidential Information shall remain confidential until it falls into one of the categories specified in this Section entitled ?CONFIDENTIALITY.?.